Content about Clinical research

October 11, 2013

A new law in Maine will allow the importation of drugs from abroad through mail-order from some pharmacies, formalizing a practice that has existed in many parts of the country for several years, and marking the first time a state government has, by law, gone against Food and Drug Administration regulations that bar importation of drugs.

Bloomberg columnist Megan McArdle said Maine was "going rogue" on drug importation, and that pretty much sums it up. The state, which has long had a close relationship with Canada — its governor, Paul LePage, is of French-Canadian descent and spoke Quebecois French as his first language — is openly defying federal law. And because federal law ultimately trumps state law, it's likely the federal government will crack down at some point.

A new law in Maine will allow the importation of drugs from abroad through mail-order from some pharmacies, formalizing a practice that has existed in many parts of the country for several years, and marking the first time a state government has, by law, gone against Food and Drug Administration regulations that bar importation of drugs.

October 10, 2013

When it comes to laws and regulations, what happens in Europe stays in Europe generally, and doesn’t have much bearing on the United States. But a recent win in Europe for U.S. drug maker Hospira could have some implications for the United States as well.

When it comes to laws and regulations, what happens in Europe stays in Europe generally, and doesn’t have much bearing on the United States. But a recent win in Europe for U.S. drug maker Hospira could have some implications for the United States as well.

Last month, the company — which specializes in making generic injectable drugs — announced that European Union regulators had approved the continent’s first biosimilar monoclonal antibody.

October 10, 2013

One of the Food and Drug Administration's top regulators is not retiring, contrary to rumors reported in news media Thursday.

SILVER SPRING, Md. – One of the Food and Drug Administration's top regulators is not retiring, contrary to rumors reported in news media Thursday.

In a memo sent out to staff, Center for Drug Evaluation and Research director Janet Woodcock wrote that she would not retire, but was becoming "more deeply involved" in such activities as proposed reorganizations of the Office of Pharmaceutical Quality and the Office of Generic Drugs.

October 9, 2013

A new law in Maine will allow consumers to purchase drugs by mail order from some pharmacies overseas, according to published reports.

NEW YORK — A new law in Maine will allow consumers to purchase drugs by mail order from some pharmacies overseas, according to published reports.

The Wall Street Journal reported Wednesday that the law, a first, had sparked lawsuits from drug companies, who say the law will threaten patient safety by opening the U.S. supply chain to counterfeit and adulterated medications. Supporters of the law, including Republican Gov. Paul LePage, say drug makers are more concerned about losing money from the law.

October 8, 2013

A Republican congressman from Alabama has proposed a stopgap bill that would fund the Food and Drug Administration through the middle of December or until the government shutdown ends, though it is unlikely to pass in the Senate.

NEW YORK — A Republican congressman from Alabama has proposed a stopgap bill that would fund the Food and Drug Administration through the middle of December or until the government shutdown ends, though it is unlikely to pass in the Senate.

October 8, 2013

The Food and Drug Administration has approved a new treatment for hot flashes and the prevention of osteoporosis, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for hot flashes and the prevention of osteoporosis, the agency said.

The FDA announced the approval of Duavee (conjugated estrogens; bazedoxifene), made by Pfizer. The drug is for women who suffer from moderate to severe hot flashes associated with menopause, and is also designed to prevent osteoporosis after menopause.

October 7, 2013

An analysis by the New York Times published over the weekend makes the case for generic drugs.

NEW YORK — An analysis by the New York Times published over the weekend makes the case for generic drugs.

Times reporter Katie Thomas opened the analysis Saturday by recalling an episode of the Netflix series "Orange Is the New Black," in which the prison saves money by switching inmates to generic drugs, much to their dismay. But that bit of artistic license on the part of the show's writers is evidence of the negative perceptions of generic drugs among the public.

October 4, 2013

A new mobile game app designed by CyberDoctor showed improvements in medication adherence, diet and exercise in diabetes patients, according to a study.

SANTA CLARA, Calif. — A new mobile game app designed by CyberDoctor showed improvements in medication adherence, diet and exercise in diabetes patients, according to a study.

The company said that breakthrough clinical trial results for the game, called PatientPartner," documented for the first time the effectiveness of a story-driven game in changing health behavior and biomarkers. The study was conducted among 100 nonadherence patients at Hershey, Pa.-based Pinnacle Health Systems and presented at the Health2.0 Conference Wednesday in Santa Clara, Calif.

October 3, 2013

The Food and Drug Administration is requiring Johnson & Johnson to use long-lasting ink in the labeling and dosage strength of an opioid painkiller patch it markets in order to make it easier to see.

SILVER SPRING, Md. — The Food and Drug Administration is requiring Johnson & Johnson to use long-lasting ink in the labeling and dosage strength of an opioid painkiller patch it markets in order to make it easier to see.

October 1, 2013

The Food and Drug Administration has approved a new drug developed by Takeda to treat major depressive disorder, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug developed by Takeda to treat major depressive disorder, the agency said.

The FDA announced the approval of Brintellix (vortioxetine) tablets for treating MDD in adults. The drug will be available in the 5-mg, 10-mg, 15-mg and 20-mg strengths.

September 30, 2013

The Food and Drug Administration has approved a drug for treating early-stage breast cancer before surgery, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for treating early-stage breast cancer before surgery, the agency said Monday.

September 23, 2013

The Food and Drug Administration has approved a drug made by Perrigo Co. for treating heart disease, the company said Monday.

ALLEGAN, Mich. — The Food and Drug Administration has approved a drug made by Perrigo Co. for treating heart disease, the company said Monday.

The FDA approved Perrigo's nitroglycerin lingual spray in the 400-mcg-per-spray strength. The drug is used to relieve attacks of or prevent angina pectoris due to coronary artery disease.

September 23, 2013

The Food and Drug Administration will not enforce regulatory requirements for most mobile medical apps because they "post minimal risk to consumers," the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration will not enforce regulatory requirements for most mobile medical apps because they "post minimal risk to consumers," the agency said Monday.

The FDA announced the issuance of guidance on the apps, saying it would adopt a "tailored policy" toward regulation, focusing its regulatory oversight on those apps that present greater risk if they do not work as intended.

September 20, 2013

Perrigo Co. has hired a former Food and Drug Administration official for its regulatory department, the drug maker said.

ALLEGAN, Mich. — Perrigo Co. has hired a former Food and Drug Administration official for its regulatory department, the drug maker said Friday.

The Allegan, Mich.-based drug maker announced the appointment of Keith Webber as head of regulatory review, a position in which he will start on Oct. 21. Webber previously served as acting director of the FDA's Office of Pharmaceutical Science, part of the Center for Drug Evaluation and Research, which regulates prescription and OTC drugs. He also served as director of the Office of Generic Drugs.

September 19, 2013

A trade group for the generic pharmaceutical industry is hoping the Food and Drug Administration will allow biosimilars to share the same generic names as their branded biologic counterparts, saying that giving biosimilars their own generic names would not enhance safety.

WASHINGTON — A trade group for the generic pharmaceutical industry is hoping the Food and Drug Administration will allow biosimilars to share the same generic names as their branded biologic counterparts, saying that giving biosimilars their own generic names would not enhance safety.

September 19, 2013

Inovalon and Walgreens on Thursday announced that they have entered into a multi-year agreement to provide Inovalon's data-driven encounter support platform, Electronic Patient Assessment Solution Suite (ePASS) within Healthcare Clinic at select Walgreens to support improvements in managed care quality and performance.

BOWIE, Md. — Inovalon and Walgreens on Thursday announced that they have entered into a multi-year agreement to provide Inovalon's data-driven encounter support platform, Electronic Patient Assessment Solution Suite (ePASS) within Healthcare Clinic at select Walgreens to support improvements in managed care quality and performance.

September 17, 2013

The Food and Drug Administration has approved a new formulation of a cancer drug made by Teva Pharmaceutical Industries, Teva said Tuesday.

JERUSALEM — The Food and Drug Administration has approved a new formulation of a cancer drug made by Teva Pharmaceutical Industries, Teva said Tuesday.

The Israeli drug maker announced the approval of a liquid formulation of Treanda (bendamustine hydrochloride), which it said would eliminate the need for reconstitution.

The drug is used to treat indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with Rituxan (rituximab), which is made by Genentech and Biogen Idec, and in patients with chronic lymphocytic leukemia.

September 16, 2013

The Food and Drug Administration has approved a drug made by Sun Pharmaceutical Industries for ulcers, Sun said.

MUMBAI, India — The Food and Drug Administration has approved a drug made by Sun Pharmaceutical Industries for ulcers, Sun said.

Sun announced the approval of lansoprazole delayed-release capsules in the 15-mg and 30-mg strengths.

The drug is a generic version of Takeda's Prevacid delayed-release capsules, which are used for treatment lasting up to four weeks for healing and symptom relief of active duodenal ulcers.

Various versions of the drug have annual sales of about $430 million per year, according to Sun.

 

September 16, 2013

The Food and Drug Administration is barring the importation of drugs from another one of Ranbaxy Labs' plants in India, the agency said Monday.

SILVER SPRING, Md. – The Food and Drug Administration is barring the importation of drugs from another one of Ranbaxy Labs' plants in India, the agency said Monday.

September 13, 2013

Companies that make long-acting opioid painkillers will be required to conduct studies to assess their safety, while use of the drugs will be restricted, under new requirements from the Food and Drug Administration.

SILVER SPRING, Md. — Companies that make long-acting opioid painkillers will be required to conduct studies to assess their safety, while use of the drugs will be restricted, under new requirements from the Food and Drug Administration.

The agency announced new labeling changes and regulatory requirements for makers of extended-release and long-acting opioids, citing the risk the drugs carry of overdose, abuse and withdrawal. In response, a group also cautioned consumers to be careful when using non-steroidal anti-inflammatory drugs.

September 12, 2013

The news that the Food and Drug Administration exceeded its hiring goals for a push that began last year to speed up review of generic drug approval applications is music to the ears of a trade group representing the industry.

WASHINGTON — The news that the Food and Drug Administration exceeded its hiring goals for a push that began last year to speed up review of generic drug approval applications is music to the ears of a trade group representing the industry.

September 11, 2013

The Food and Drug Administration has exceeded its goals for hiring new staff as part of a user-fee law for generic drugs, according to an internal memo sent to staff members.

SILVER SPRINGS, Md. — The Food and Drug Administration has exceeded its goals for hiring new staff as part of a user-fee law for generic drugs, according to an internal memo sent to staff members.

In a memo to staff of the agency's Center for Drug Evaluation and Research, center director Janet Woodcock wrote that for fiscal year 2013, the FDA hired 234 people as part of the Generic Drug User Fee Amendments Human Capital Team. The goal was to hire 231 as part of a three-year push in which it hopes to hire 921, including 461 during fiscal year 2014.

September 10, 2013

The country's embryonic biosimilars industry scored a victory last month as the organization that runs the pension fund for California state employees announced its opposition to a state Senate bill provision that would impose special requirements on pharmacists who dispense follow-on biologics.

The country's embryonic biosimilars industry scored a victory last month as the organization that runs the pension fund for California state employees announced its opposition to a state Senate bill provision that would impose special requirements on pharmacists who dispense follow-on biologics.

September 10, 2013

A new set of guidelines from the Food and Drug Administration could bring a generic version of a respiratory drug made by GlaxoSmithKline closer to reality.

NEW YORK — A new set of guidelines from the Food and Drug Administration could bring a generic version of a respiratory drug made by GlaxoSmithKline closer to reality.

The FDA guidelines, a set of non-binding recommendations released Monday, outline studies that manufacturers can conduct to determine equivalence between GSK's Advair Diskus (fluticasone propionate; salmeterol xinafoate) and generic versions.

September 10, 2013

While the U.S. generic drug market has grown at a rapid pace, the international market for generic manufacturing and use has grown as well.

While the U.S. generic drug market has grown at a rapid pace, the international market for generic manufacturing and use has grown as well.